2020 PDA Annual Meeting

Enhancing the Future with Innovative Medicines and Manufacturing

July 20 - 22 2020, Virtual

away

PDA Statement Regarding COVID-19 and the 2020 PDA Annual Meeting

PDA has implemented a set of measures to protect participants at PDA events from potential risks related to COVID-19 as best as possible. This includes a close and regular monitoring of the situation, adherence to recommendations of health authorities and official travel warnings, possibilities of remote presentations, and precautions being implemented at our venues.

Regarding the 2020 PDA Annual Meeting, we have been following the situation very closely. In light of the situation with a growing number of our participants not being able to travel, the 2020 PDA Annual Meeting will now be a fully virtual event. All registrations will be transferred to the new dates without penalty. The website will be updated shortly.

We recognize the challenge this may cause, and we apologize for the inconvenience. Like you, we are trying to respond to the changing situation.

Overview

The theme of the 2020 meeting is Enhancing the Future with Innovative Medicines and Manufacturing. In selecting this theme, the planning committee designed a comprehensive event that encompasses the wide-ranging interests of all PDA members. Whether you are focused on improving existing processes or delving into entirely new technologies, the PDA Annual Meeting will cover relevant information important to small molecule, and biopharmaceutical, cell and gene therapy and other modalities.

Plenary sessions will inspire all of us to engage as we focus on the importance of what we do every day to improve the quality of life for millions of people. It is a daunting and empowering task we are faced with and these sessions will focus on key aspects of our work including getting personal with patients, understanding regulations, leveraging breakthrough designations, modernizing facilities, strategies for developing next generation medicines, and protecting integrated systems from external threats. Concurrent session tracks include, Developing New Modalities, Targeting Real-Time and Parametric Release, Engineering Data Solutions, and Modernizing Products and Manufacturing.

Rounding out the program are Interest Group sessions, which offer participants a chance to hear from experts as well as engage in interactive discussions on a variety of important topics and specific disciplines.

The virtual exhibition hall provides opportunities for one-on-one interactions with service providers and vendors who will showcase their latest services and technologies. Authors of numerous poster presentations will also be present to discuss their latest research and data. Breaks are scheduled throughout the meeting to allow time for further virtual networking and peer-to-peer discussions.

This virtual meeting is a ‘must attend’ knowledge sharing event for everyone, from corporate executives to those who have recently joined the industry, it is an ideal opportunity to accelerate your impact and position in your company as well as in the pharmaceutical industry.

Sponsors

Platinum Sponsors

Gold Sponsors

Silver Sponsor

Get Involved

The New Era of Innovative Medicines and Manufacturing

PDA’s flagship Annual Meeting provides an opportunity for obtaining the latest and most comprehensive information on a broad range of topics related to product and process development, manufacturing, supply chain, and quality. Moreover, the meeting provides a robust venue for learning, networking, and benchmarking with respect to innovation and continuous improvement.

20

Sessions

40

Hours of Content

700

Attendees

40

Speakers

Speakers

Ketherine M. Hebert

Ketherine M. Hebert

Regeneron Pharmaceuticals

Kate Hebert is a Senior Quality Assurance Training Specialist at Regeneron Pharmaceuticals, Inc. She earned a master’s degree in Curriculum Development and Instructional Technology from University at Albany, in Albany, New York. Her research interests include instructional design, curriculum design, and emerging technologies.

Joe Neroni

Joe Neroni

Project Farma

Joe has over 10 years of experience in leading and supporting cross-functional teams in Capital Projects, Medical Device, and Validation in the Pharmaceuticals, Biotechnology and Gene Therapy Industry, Food and Beverage, and Aerospace industries. Joe is a Director at Project Farma supporting the Mid-West and East Coast Operations and has extensive experience leading local and global teams up to 30+ team members in Capital Projects, Commissioning & Qualification, Engineering, and Project Management in the pharmaceutical and biopharmaceutical industry.

He has held multiple roles ranging in a wide variety of scope and responsibility from Project Management, Engineering Technical Lead, and Commissioning and Qualification Lead for Gene and Cell Therapy Facility Builds, Medical Device, Business Strategy, Technical Operations advisement and Facility Remediation. Joe has a strong technical background in Upstream, Downstream and Fill and Finish processes through the project life cycle from conceptual design through implementation with a proven adaptability to new situations demonstrated by successful projects in a variety of companies and industries involving new or improved facilities, infrastructure, utilities and process equipment.

Cori Sandy, CQA

Cori Sandy

AveXis, A Novartis Company

Cori Sandy is the Associate Director of Quality Systems at AveXis, a Novartis company, responsible for developing core quality systems for a new North Carolina gene therapy manufacturing facility. Prior to this, she was in a Corporate Quality role responsible for management of the quality management system (QMS) and development of a quality risk management (QRM) program. Cori has over 20 years industry experience in quality roles at Glaxo, Novo Nordisk, Biogen and AveXis. Experiences include quality remediation, aseptic processing, QC Chemistry, labelling/packaging, regulatory intelligence, QMS, QRM, data integrity, deviation and CAPA management, change management, and auditing. She is a Certified Quality Auditor (CQA), holds a BS degree in Business Administration and is currently attending NC State University for her MBA. Cori is a North Carolina native and lives with her family in nearby Apex, NC.

Ashley E. Giambrone, PhD

Ashley E. Giambrone

Regeneron Pharmaceuticals

Ashley Giambrone is a Associate Manager in Continuous Improvement - Statistics at Regeneron Pharmaceuticals, Inc. She was an Assistant Research Professor at Weill Cornel Medical College in New York City, New York. She earned a doctorate degree in Biostatistics from University at Albany, in Albany, New York. Her research interests include categorical data analysis, teaching, and training program management.

Kevin D. Wojtas

Kevin D. Wojtas

Takeda Pharmaceuticals

Kevin D. Wojtas leads the Global Quality, Regulatory Compliance group for Takeda which includes leadership of the GxP Data Integrity Program across all sites and functions. He has 25 years of success in the Pharmaceutical and Medical Device industry including positions in Manufacturing, QC, IT, Validation and Quality.

Kevin has a passion for collaborating with global teams, supporting individuals on their career journey and finding ways to help Takeda improve the lives of patients.

Tom G. Whitehead

Tom G. Whitehead

Emily Whitehead Foundation

Tom Whitehead is co-founder of the Emily Whitehead Foundation, which raises funds and awareness for pediatric cancer immunotherapy research. Tom and his wife Kari founded the Emily Whitehead Foundation in honor of their daughter Emily who was diagnosed at age five with an aggressive form of leukemia that failed to respond to chemotherapy. As a last hope, Emily was enrolled in a clinical trial and became the first pediatric patient in the world to receive CAR-T cell therapy. The therapy worked and Emily is now more than 7 years cancer free.

Greg Gara

Greg Gara

Sarepta Therapeutics

Greg R. Gara has over 25 years of experience in the biotechnology field specializing in designing, constructing, and starting up large and small scale manufacturing facilities throughout the world. Greg recently joined Sarepta as the VP of Pharmaceutical Engineering. Prior to joining Sarepta, he designed, constructed, and started up the facility located in North Chicago for AveXis, a Novartis company, led the team for the facility expansion in North Carolina, in addition to renovating the recently acquired Colorado site. Greg and his team were responsible for the design, construction, startup, and commissioning of the new facilities being constructed in Research Triangle Park and Colorado. Prior to AveXis, he led the facilities and engineering organization at Hospira prior to the Pfizer acquisition. Before joining Hospira, Greg spent 15 years working for Amgen and was part of the Cork Ireland construction project.

Jose E. Soto, PhD

Jose E. Soto

GlaxoSmithKline

Dr. Jose Soto is currently the Director for Data Compliance and Governance at GlaxoSmithKline where is responsible for leading the identification of global data integrity standards and solutions for the control GxP Data and Documentation in support of the Global Data Integrity Strategy. He has over 19 years of experience in the Pharmaceutical Industry in QA and QC operations. He holds a Ph.D. in Chemistry from Texas A & M University.

Cory Proctor

Cory Proctor

Project Farma

Cory Proctor has over 10 years of experience in capital projects, medical device, and validation in the Pharmaceuticals, Biotechnology and Gene Therapy Industry. He has extensive experience leading teams of 20+ team members in Project Engineering, Project Management, Commissioning & Qualification, and Automation in the pharmaceutical and biopharmaceutical industry. Cory is currently the Director of West Coast Operations at Project Farma. He has held multiple project lead roles with the most recent being Project Manager for a gene therapy Tech Transfer. He has led diverse, cross-functional teams of up to 25 throughout the entire project lifecycle including project initiation/funding requests, business case development, conceptual design, basis of design, detailed design, construction, commissioning/qualification, validation, project close-out/purchase order closure. He has also managed and supported development of regulatory approach, project strategies and user requirements specifications for primary and secondary package inspection and track and trace serialization in alignment with the industry guidelines, US and foreign regulations.

Russell E. Madsen, MS

Russell E. Madsen

The Williamsburg Group, LLC

Russell E. Madsen is President of The Williamsburg Group, LLC, a consulting firm located in Gaithersburg, Maryland. Prior to forming The Williamsburg Group, he had served PDA as Acting President and was Senior VP Science and Technology. Before joining PDA, he was employed by Bristol-Myers Squibb Company as Director, Technical Services, providing technical and general consulting services to Bristol-Myers Squibb operations, worldwide. He is Vice-Chairman of ASTM Committee E55 on Manufacture of Pharmaceutical and Biopharmaceutical Products, a member of the USP Microbiology Expert Committee, Chairman of the USP Visual Inspection of Parenterals Expert Panel, a member of Pharmaceutical Technology’s Editorial Advisory Board, and an Honorary Member of PDA. He holds a Bachelor of Science degree from St. Lawrence University and a Master of Science degree from Rensselaer Polytechnic Institute.

Jeff Galvin

Jeff Galvin

American Gene Technologies

Jeff Galvin is the CEO and Founder of American Gene Technologies™ (AGT). He earned his BA degree in Economics from Harvard in 1981 and has more than 30 years of business and entrepreneurial experience including founder or executive positions at a variety of Silicon Valley startups. Several of his companies were taken public and/or sold to public companies, including one in the medical-technology arena that was sold to Varian, the leading maker of linear accelerators used in cancer therapy. Following his startup experience, he retired to become an Angel Investor in real estate and high tech. He came out of retirement to found and fund AGT after meeting Roscoe Brady at NIH.

Ramila H. Peiris, PhD

Ramila H. Peiris

Biogen

Ramila Peiris manages Biogen’s Applied Analytics and Operations Team and is responsible for developing and deploying data management and analytics solutions for process monitoring and process diagnostics. He is an experienced data science professional with over 10 years of experience in the biopharmaceutical industry.

Ramila has a master’s degree and PhD in Chemical Engineering, with specializations in process modelling and optimization. He is passionate about driving innovation through digital transformation and using advanced data analytics techniques to unearth business value from data.

Prior to L7 Informatics, Dr. Rangadass was the Chief Strategy Officer at NantHealth following its acquisition of Net.Orange, the company he founded to provide an enterprise-wide platform - Clinical Operating System (cOS) to simplify and optimize care delivery processes in health systems. As CEO of Net.Orange, Vasu is patented and developed an innovative healthcare framework (cOS™ - Clinical Operating System™) that results in superior performance for Healthcare Organizations and revolutionized the way healthcare IT systems are architected.

Kathleen S. Souza, MS

Kathleen S. Souza

MilliporeSigma

Kathleen Souza is an R&D Manager in the Virology & Microbiological Sciences Group. She has over 30 years’ experience in the field of microbiology. Her work has focused on the biopharmaceutical industry, and she currently leads a team developing products and methods for microbial retention, microbial integrity of single-use products, bioburden & sterility testing, preservative & santitant effectiveness, environmental monitoring and microbial detection. She is an author of the PDA Technical Report on Alternative Methods for Mycoplasma Testing focused on detection technologies for mycoplasma. Additionally, she is co-chair of the TR45 revision on Depth Filtration and Prefiltration.

Kathy A. Demarest

Kathy A. Demarest

Amgen Inc.

Kathy joined Amgen in 2002 and is the Executive Director of Site Quality. Kathy was born in Providence, RI. She attended high school in nearby Cranston and attended Dickinson College in Carlisle, PA where she studied physics and mathematics and played on the volleyball team. Upon graduation, she attended the University of RI for graduate physics courses. She started her career as a GC/MS analyst for an environmental laboratory in Syracuse, NY. In 1992, Kathy began a ten year career in various roles in the laboratory and validation departments at Merck Pharmaceuticals in West Point, PA prior to coming to Amgen.

Kathy’s roles at Amgen have included computer validation, Lab QA, CMQA Disposition, AR5 Production, QC, Quality Operations and her current role as Executive Director of Site Quality. Kathy lives in Cranston, RI. Her only daughter Karen is a junior at Stonehill College in Easton, MA.

Diego A. Zurbriggen

Diego A. Zurbriggen

West Pharmaceutical Services

Mr. Zurbriggen has over 20 years of analytical lab experience, 10 of which focused on inorganic trace level analysis. As Technical Account Manager within the Technical Customer Support group of West, the focus of his role is to provide technical support relating to West’s packaging components and delivery systems for injectable drugs and healthcare products. He serves as the West subject matter expert on Extractables & Leachables, including elemental impurities.

Prior to this role, he was Supervisor of the Leachables/Stability group in the Analytical Labs division of West Pharmaceutical Services, Inc., the focus of his role was to develop and validate leachables methods. Mr. Zurbriggen holds a Bachelor of Science/Chemistry degree from the Gewerbliche Berufsschule Visp – Visp, Valais, Switzerland.

John Khoury

John Khoury

Project Farma

John Khoury is a 20+ year veteran and leader in the biotech / pharmaceutical industry. As a member of the Project Farma Leadership Committee, John has spearheaded Project Farma’s growth in the gene and cell therapy space. He has led and provided strategy on key partner initiatives including make vs. buy analysis, site and vendor selection, tech transfer execution strategies, and facility start-ups.<br>In addition to his experience in advanced therapies, John has extensive experience with small and large molecules including biologics and biosimilars. Over the past four years, he has led facility builds totaling over $500MM. During this time, he has worked with small and large biotech and pharmaceutical companies including gene and cell therapy startups and CMOs/CROs.

Renne T. Morley, MBA

Renne T. Morley

Contec Inc.

Renee Morley is a Senior Technical Services Specialist for Contec, Inc. providing expertise and evaluation regarding industry best-practices and technical applications of disinfectants solutions, wipers, and mops for use in cleanroom and other controlled environments. She has over fourteen years of experience leading training on contamination control in cleanrooms and providing technical support related to critical environments, process research cleaners, and cleaning validation. Ms. Morley is a valuable resource in the areas of site evaluations, training and technical presentations, and educational seminars.

Ms. Morley was President of the Parenteral Drug Association’s Southeast Chapter (PDASE) from 2016-2019 and held other various positions within the organization including the Networking Chair. In 2018, Renee was the PDA Volunteer Spotlight which PDA awards to active volunteers in the organization. Renee received an MBA from Lake Erie College in Painesville, Ohio, and a BA in Marketing from Ohio University in Athens, Ohio.

Kristin N. Valente, PhD

Kristin N. Valente

Candis Morrison, PhD, ACNP

Candis Morrison

U.S. FDA

Candis Morrison is a Senior Clinical Analyst at the Food and Drug Administration in Silver Spring Maryland. Her work includes clinical reviews of; applications for New Drug Approvals, Investigational New Drug trials, as well as new indication supplements for the Division of Hematologic /Oncology Products 2.

Candis earned a Master’s degree in administration and psychiatric nursing. Her doctoral studies focused on stress and psychoneuroimmunology, and she earned her PhD in Health Education. She developed programs for, and taught nurse practitioner students, at the Johns Hopkins University School of Nursing while practicing in the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins and the Johns Hopkins Bayview campus.

She has practiced in the areas of hematology and hematologic malignancies for more than twenty years, working with teams in which she contributed to protocols, worked with sponsors, and authored publications. She continues to practice in the Division of Lymphoid Malignancies at the National Cancer Institute where she is part of a multidisciplinary team caring for multiple myeloma patients on clinical trials.

When not working, Candis enjoys skiing, spending time with her five sons, and volunteering with animal rescue organizations in, and around, Washington, DC.

Mayda C. Mercado, MA

Mayda C. Mercado

Kite Pharma

Mayda Mercado is a Biopharmaceutical and Cell & Gene Therapy Quality (GxP) Executive with over 28+ years of experience. She started at Smith-Kline Beecham-Clinical Reference Laboratories working in the areas Microbiology, Hematology , Immunology and Management. Then worked for Johnson & Johnson (Ortho Biologics, Centocor, and Jansen) in various leadership and managerial roles in management of QC Laboratories, Compliance, and Supply Chain. Then, she moved to Pfizer (Wyeth) to manage Biologics Quality Product Leaders, and Site Parenteral Quality Site Head. These experiences increased her knowledge of Global Regulatory Requirements and Operational Excellence transformation. She then moved to Merck to lead the Global Biologics Quality Network of sites where she managed commercialization and approval of key Biologics. Then she moved to start up facilities with a focus on Biosimilars; TPI & PFENex to lead and build the Quality Organization and CMC-Regulatory. She then joined Kite, a Gilead Company as an ED, Quality Site Head, and most recently advanced to a corporate role as Executive Director, Global Quality and Compliance in Santa Monica, California.

Mayda earned a Masters in Business Administration from University of Phoenix, a Bachelor in Medical Technology from University of Kentucky and a Bachelor in Biology from Interamerican University

Jason Kerr, MBS

Jason Kerr

Amgen Inc.

Jason Kerr is a QA Specialist at Amgen's External Affairs Quality department. He ensures regulatory compliance by identifying risks to Amgen and enables Amgen to mitigate these risks through appropriate escalation. Jason monitors global regulatory intelligence to assess GXPs changes and how they might impact Amgen's quality processes. Before Amgen, Jason worked as a material qualification engineer analyzing extractables and leachables on single-use systems and raw material for commercial drug products. He received his Bachelors in Biochemistry from UCLA in 2014 and his Masters in Business and Science (MBS) focusing on Clinical and Regulatory Affairs from the Keck Graduate Institute (KGI) in 2016. He also holds a Certificate in Bioscience Industry Law and Practice from the Southwestern Law School in 2016.

Derek R. Gallo, BS

Derek R. Gallo

Thermo Fisher Scientific

Derek Gallo is the Director of Global Technology Transfer at Thermo Fisher Scientific. Derek Gallo is the current head of Technology Transfer for the Drug Product division across North America and Europe at Thermo Fisher Scientific. He is passionate about developing new best practices and tools for the global and site project management teams to improve and evolve how teams manage TT projects – both internally and for customers within the CMO space. In this current role Derek supports over 100 TT projects with launching 30-40 new products annually. Prior to this role, Derek managed a tech transfer team who was responsible for 16 new product launches. Derek has experience in steriles, solid dosage, soft gel, and biologics within the pharma industry and previously held roles including as a project manager, validation engineering, R&D, and production operations.

Crystal M. Booth, MM

Crystal M. Booth

PSC Biotech

Crystal M. Booth, M.M., is a Regional Manager a PSC Biotech and has over 20 years of experience in pharmaceutical microbiology, environmental monitoring, and quality assurance. She obtained her master’s degree in microbiology from North Carolina State University. Crystal is a seasoned award winning technical writer and author of Method Development and Validation for the Pharmaceutical Microbiologist. During her career, Crystal has worked in microbiology, consulting, quality assurance, CDMOs, R&D, and quality control laboratories. Crystal has developed and validated numerous microbial methods and has worked with many different product types.

Marc G. Glogovsky, MS, SM (NRCM)

Marc G. Glogovsky

Valsource LLC

Marc Glogovsky, MS, S.M. (NRCM) has over 20 years’ experience in the pharmaceutical industry, specializing in aseptic operations, contamination control, and risk-based environmental monitoring. He has written a number of publications involving rapid microbiology, environmental monitoring, Mycoplasma and MALDI-TOF microbial identification. Currently, he is a Senior Microbiology Consultant with ValSource, Inc. Prior to joining ValSource, he was responsible for managing the Environmental Monitoring Control division at Veltek Associates, Inc., and more than 10 years as a senior microbiology specialist at Merck KGaA. Marc earned his B.S. in Biology from Monmouth University and his M.S. in Microbiology from Rutgers University.

Marc is actively involved with Parenteral Drug Association, where he serves on PDA’s Science Advisory Board, Education Advisory Board, chairs the Microbiology/EM Interest Group, is a faculty member at PDA-TRI and has contributed to a number of technical report committees and is currently co-chairing the Microbial Data Deviation technical report and a revision of the Environmental Monitoring (TR-13) technical teport.

Kimberly Duffy

Kimberly Duffy

Merck & Co. Inc.

Ms. Duffy has been with Merck since 1988, her entire career in the vaccine manufacturing field. Kim's first position was as a technician in viral vaccine manufacturing and she has held positions in Quality Control, Laboratory Operations, Vaccine Manufacturing, and Regulatory Affairs. Kim joined the Regulatory CMC group in 2007 and has managed global registrations and post-approval changes for a variety of vaccines; specializing in US, Europe, Japan, and China.

Amanda M. McFarland, MS

Amanda M. McFarland

ValSource LLC

Amanda McFarland is a Senior Consultant for ValSource and in this role assists companies with the design and implementation of CGMPs, Microbiology, and Quality Risk Management programs. She specializes in the creation and implementation of risk management programs, developing risk-based strategies and risk facilitation. Prior to joining ValSource, Amanda worked to integrate a global risk management program by developing the procedures required and training the organization in the execution of consistent risk management tools.

Ms. McFarland currently serves as the PDA QRM interest group co-lead, the PDA SE chapter Secretary and is a faculty member of the Quality Risk Management Certificate Training Series at PDA training institute.

Jane L. Halpern, PhD

Jane L. Halpern

Independent Consultant

Jane Halpern, Ph.D. is an independent consultant for the biologic and biotechnology industries, specializing in regulatory strategy and CMC guidance.

Dr. Halpern has over 25 years of experience in biologics development and has held positions in government as well as both small and large biotech companies. She worked at the FDA, Center for Biologics Evaluation and Research (CBER) as a researcher/reviewer for 10 years where she reviewed applications for both investigational and commercial products. At CBER she participated in inspections and the development and implementation of regulations, policies, and guidance documents.

Dr. Halpern has held senior management positions at ID Biomedical Corporation, GSK Biologics, and Novavax Inc. At ID Biomedical Corporation, she led the global regulatory team that was responsible for obtaining FDA accelerated approval of a seasonal influenza vaccine and that supported the acquisition of ID Biomedical by GSK.

Dr. Halpern has been a committee member for previous PDA Vaccine conferences and currently serves as a co-chair of the PDA Vaccine Interest Group. She received her B.S. in Physiology from the University of California, Davis and her Ph.D. in Pharmacology from the University of Rochester.

A. Sabrina Restrepo, PhD

A. Sabrina Restrepo

Sabrina Restrepo, Ph.D. Director – Global Vaccines Technical Operations, Merck & Co. Inc. Sabrina's responsibilities at Merck have included technical operations support in several areas such as deployment of single-use systems in vaccine manufacturing, process improvements for vaccines manufacturing, subject matter expertise in extractables and leachables, technical collaborations with single-use systems’ suppliers, regulatory remediation plans, and vaccines technology transfers with External Partners. Recently, she was a recipient of the 2018 Frost & Sullivan Manufacturing Leadership Award in the Engineering and Production Technology Leadership category for the Design, Evaluation and Implementation of Single-Use Components for Ebola Zaire Vaccines Drug Substance Manufacturing. Currently, she is the co-lead of the PDA Vaccines Interest Group.

Prior to joining Merck, she worked at Irvine Scientific, Allergan and the Instituto Colombiano del Petróleo where she contributed to the development and manufacturing of cell culture media products, large molecule process characterization and improvement and development of biological wastewater technologies, respectively.

Sabrina has published four technical publications, received four recognitions within Merck, co-authored three BioPhorum Industry documents, and presented at numerous conferences.

She holds a BS and MSc degrees in Chemical Engineering from Universidad Nacional de Colombia and PhD degree in Engineering from the University of Akron, Ohio.

Beth J. Haas, MChE

Beth J. Haas

Commissioning Agents, Inc.

Beth has focused much of her 28 year career performing new product introductions and technology transfers. She has commercialized 20+ products across a variety of industries including small molecule APIs, drug product, specialty chemicals, thin film, and commodity chemicals Using her knowledge of ICH guidances, she enjoys helping both large pharma and virtual companies identify key focus areas for product development, transfers, and scale-up. Her in-depth understanding of criticality enables her to guide organizations in defining accurate critical quality attributes, critical process parameters, and critical aspects for process equipment and laboratory systems. Beth joined the PDA Technology Transfer Interest group in 2015 where she has focused on building a generic tool for guiding technology transfer program management and most recently, worked with PDA on a wide ranging survey on Technology Transfer. She wants to build the PDA TT IG community with cross-functional expertise where knowledge on technology transfer strategies and best practices can be shared.

Arne Zilian, PhD

Arne Zilian

Novartis

Arne has 20 years of experience in the Pharmaceutical Industry. He has worked in Analytical Development, Chemical Development, Pharmaceutical Development, Manufacturing Operational Excellence and Manufacturing Science and Technology.

In Novartis, he is the global program lead for ‘Predictive Processing’ and for Continued Process Verification. He serves as the lead author for the corporate quality standards for process validation and for CPV. Over the last years, he was instrumental in building the Manufacturing Science and Technology organization.

In PDA, he is engaged in the interest groups for CPV and Manufacturing Intelligence.

Arne holds a Ph.D. in Analytical Chemistry and a Master in Chemistry. He is also a Agile/ Scrum master and certified Kepner Tregoe trainer for situation, decision and problem analysis.

Toni Manzano, PhD

Toni Manzano

Bigfinite

Toni Manzano is Cofounder and CSO of Bigfinite, a SaaS company that is transforming manufacturing operations with the use of AI and IIoT technologies for pharmaceutical and biotech companies. For over two decades, he has led software projects for international pharmaceutical companies covering the entire production process and supply chain. Today, Toni is a part of the scientific committee with PDA Europe and with the AI Xavier Manufacturing team. He worked as a researcher at the University of Barcelona as a physicist and teaches big data and artificial intelligence in postgraduate courses at the UAB. He is also a member of the Science Experts in the Spanish Parliament on big data and artificial intelligence. He has written numerous articles and holds a dozen international patents related to the encryption, transmission, storage, and processing of large volumes of data for regulated environments in the cloud.

Anthony M. Pavell, MS

Anthony M. Pavell

Fresenius Kabi

Tony has over 25 years of parenteral manufacturing experience primarily focused in operations and technical services. He is currently working as Plant Manager for the Fresenius Kabi Grand Island Production Unit. Tony received a Master of Science degree in Molecular Biology and Biotechnology from East Carolina University. Tony has also been a PDA member for over 20 years.

Martha J. Folmsbee, PhD

Martha J. Folmsbee

Pall Corporation

Martha Folmsbee is a Principal Scientist in the Scientific and Laboratory Services department at Pall Corporation, based in Port Washington, NY. Martha specializes in bacterial and bacteriophage retention testing of sterilizing grade filters. Her work includes a special focus on mycoplasma clearance and sterile filtration of complex fluids. Martha received a Masters in Environmental Science from the University of Oklahoma in 1997 and later her PhD in Microbiology in 2004. For her PhD dissertation, she studied the physiology and nutritional requirements of anaerobic growth and biosurfactant production of Bacillus mojavensis and several other bacilli. In 2005, she was awarded an ASM/NCID (American Society for Microbiology/National Centers for Infectious Disease) Post Doctoral Fellowship to work at the CDC (Center for Vector Borne Disease) in Fort Collins, CO.

Austin G. Caudle, MSc

Austin G. Caudle

MedSurgPI

Mr. Caudle is Associate Director of Emerging BioPharma R&D Solutions at IQVIA, the Human Data Science Company™ that mobilizes unparalleled data, analytics, technology, and expertise through solutions connecting stakeholders to improve health. He has business experience across pharmaceuticals, biotech, and medical devices helping clients to proactively interpret regulations, understand processes and product technologies, make sound decisions, facilitate change, and drive business benefit. He assists Emerging BioPharma companies plan and implement highly targeted, data-driven clinical trials to advance an asset from first-in-man through global Phase III studies. Mr. Caudle currently serves as President-Elect on the Board of Directors for the Parenteral Drug Association in the Southeast U.S. and on several conference planning committees. He holds an MS in Food Science and a BS in Nutrition Science from Auburn University.

Peter J. Makowenskyj

G-CON Manufacturing

Peter Makowenskyj has over 13 years of experience in pharmaceutical and biopharmaceutical industries. Peter held various technical roles in process solutions for the biotech industry prior to moving into management positions in technical and sales roles. He has extensive knowledge of bioprocess manufacturing and helped design new facilities and retrofit existing facilities with single use technologies. Peter joined G-CON Manufacturing in 2016 where he now consults with clients in the design of their facilities utilizing G-CON’s pre-fabricated autonomous clean rooms.

Peter received his Bachelor of Science in Chemical Engineering and a Minor in Biomedical Engineering from Cornell University. He received is M. Eng in Chemical Engineering from Cornell University.

Michael J. Abernathy, MS, RAC

Michael J. Abernathy

Amgen Inc.

Michael Abernathy, Executive Director, leads Amgen’s Global RA CMC function and is accountable for staff globally, and a product portfolio of over 80 programs. The extent of Michael’s product oversight and responsibilities traverse molecular discovery, early and late-stage clinical development and approved life-cycle programs. He also leads Amgen’s external engagement activities that comprise a CMC focus, promoting company and industry initiatives, engaging with Health Authorities around the world and contributing to industry organizations. Michael made significant contributions to a recent paper publication on novel modalities and emerging technologies titled “Innovation in Chemistry, Manufacturing, and Controls – A Regulatory Perspective From Industry”, Journal of Pharmaceutical Science, (2019).

Prior to his current post, Michael has held roles of increasing leadership at Amgen, including active contributions to several of Amgen’s commercialized therapeutics, as well as spearheading the company’s Analytics Optimization initiative. Michael has been an active contributor to innovation during his 20 years as a Regulatory Affairs professional. Prior to joining Amgen, he held a leadership role within Atrix Laboratories/QLT, Inc.’s Regulatory Affairs group. Mr. Abernathy holds degrees from University of the Pacific, California State University and Colorado State University.

Michele C. D’Alessandro, MBA

Michele C. D’Alessandro

Merck & Co., Inc.

Michele is Vice President and CIO for the Manufacturing Division with Merck. In this role, she provides strategic leadership, oversight and delivery of information technology and digital solutions for the Merck Manufacturing Division. A change agent with proven track-record of delivering high-impact projects producing outstanding business results broadly across Pharmaceutical Supply Chain and Manufacturing.

Michele and her team have been nationally recognized for the past 5 years in the areas of technical innovation, including next generation data and analytics platforms; supply chain transformation; and modernization/ digitization in manufacturing plants. In Nov 2017, Michele was awarded a Gold Stevie® Award for Women in Business in the Life Sciences and Healthcare Transformation category.

Michele holds a Bachelors’ double major degree in Math and Computer Science from Rutgers University and an M.B.A. in Information Sciences from Rutgers Graduate School of Management.

Michele serves on the National Association of Manufacturer’s Manufacturing Leadership Council Board of Governors, CNBC’s Technology Executive Council, the Strategic Advisory Board for enigma.io, and the Big Data Advisory Board for Rutgers University.

Aaron R. Goerke, PhD

Aaron R. Goerke

F. Hoffmann-La Roche

Aaron R. Goerke has over 15 years of industry experience in supporting pharmaceutical and biotechnology companies in the areas of process development, manufacturing and quality systems. In his various roles, he has been responsible for developmental projects ranging from discovery to Phase III and supporting internal and external Biologics and Vaccine manufacture. Aaron’s recent roles include Head of Global Engagement and Deployment at Hoffmann-La Roche and as Head of Downstream Global MSAT at Genentech, which included responsibility for CMO technology transfers ensuing supply agility, maintaining Make-Assess-Release efforts ensuring supply to patients, and ownership of various network strategic initiatives. Efforts include serving as the Head of the Roche Process & Product monitoring program, establishing a Global Performance Analysis program spanning Large and Small Molecules and conceptualizing an IT solution in the age of “big data.” Aaron is currently Director of MSAT at Roche Singapore Technical Operations. He holds a Ph.D. in Chemical Engineering from Stanford University and has published a large number of peer-reviewed journal articles and patents, had numerous external presentations and has been presented a number of academic and professional awards.

Kelly Waldron, PhD

Kelly Waldron

Valsource LLC

Dr. Kelly Waldron is currently a senior consultant with ValSource and a member of the Pharmaceutical Regulatory Science Team (PRST) at the Technological University Dublin (formerly Dublin Institute of Technology) in Dublin, Ireland. She has particular expertise and a specialized focus on the development and implementation of innovative approaches to quality risk management (QRM) and has authored numerous industry and academic papers on the topic. Dr. Waldron’s expertise extends to various quality functions in the pharmaceutical, biopharmaceutical, and medical device industries, including quality system design, quality strategy and planning, deviations/investigations, CAPA, change management, data integrity, audit and inspection programs and response, and design control. She holds a BA in biology from Boston University, an MBA in pharmaceutical management from Fairleigh Dickinson University, and a Ph.D. in pharmaceutical regulatory science (thesis in QRM) from the Dublin Institute of Technology. She currently resides in New Jersey, USA and can be reached at [email protected]

Melissa S. Seymour, MBA

Melissa S. Seymour

Biogen, Inc.

Melissa Seymour is the Vice President of Global Quality Control for Biogen, Inc., assuming responsibility for the comprehensive strategy and implementation for Global QC testing of Raw Materials, Drug Substance, Drug Product and Finished Goods worldwide. Prior to this, Melissa served as the Vice President of Corporate Quality with responsibility for global compliance and quality systems including management of Quality Systems, Internal and External Auditing and Global Affiliate GMP oversight. Melissa holds BS degrees in both Biological Sciences and Biochemistry from North Carolina State University and an executive MBA from Duke University. Melissa has over 20 years of experience in the quality arena including quality positions at Novo Nordisk pharmaceuticals and Glaxo Smith Kline. Melissa has been highly active in the Southeast chapter of PDA for the last 5 years as a member of the local board, serving as Vice-President, President, and most recently, Past President. She was recently elected to the Board of Directors for PDA. Melissa is an ASQ Certified Quality Engineer, Certified Quality Auditor and Certified Quality Manager and has previously served on the Board of Directors for the Rx-360 Consortium focused on supply chain security.

Emma Ramnarine, MS

Emma Ramnarine

Genentech/Roche

Emma Ramnarine is the Global Head of External Development Collaborations at Genentech/Roche. She leads outsourcing strategies and manages the external clinical development, manufacturing, and clinical collaborations network for Roche’s Biologics and Small Molecules development portfolio.

Emma has 20+ years of experience in the pharmaceutical, biotechnology and medical device industry in Analytical Science & Technology, Quality Control, Risk Management and Quality System Management. She is a worldwide-recognized expert on Quality Risk Management (QRM), providing QRM training to regulatory authorities and at industry forums.

Emma is currently on the PDA Board of Directors and is co-leading PDA’s Post Approval Change Task Force.

She has additionally led several other PDA Task Forces and Technical Reports, and also served on PDA’s Regulatory Affairs and Quality Advisory Board (RAQAB).

Ashley B. Boam, MSBE

Ashley B. Boam

U.S. FDA

Ashley Boam currently serves as Director of the Office of Policy for Pharmaceutical Quality (OPPQ) in the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER). OPPQ is responsible for developing and clearly communicating science- and risk-based policies and standards related to drug product quality, including application review and inspection. OPPQ also coordinates OPQ’s work with international regulatory authorities on quality issues, leads CDER’s compendial operations, coordinates CDER’s involvement in quality standard-setting organizations, and addresses policy issues related to drug-device combination products.

Prior to joining CDER in 2013, Ashley spent nearly 20 years in the Office of Device Evaluation (ODE) in FDA’s Center for Devices and Radiological Health (CDRH), serving as a scientific reviewer, a Branch Chief in the Division of Cardiology Devices, and finally as Associate Director for Regulations and Guidance for ODE. Ashley received her MSBE from the University of Alabama at Birmingham and her BSE from Tulane University, both in Biomedical Engineering.

Shelley M. Preslar, MBA, PMP

Shelley M. Preslar

Azzur Group Raleigh

Shelley Preslar is a wife, mother, grandmother, business owner and Veteran. With more than two decades in life sciences, Shelley is General Manager at Azzur Group Raleigh, located in North Carolina, where she leads a team of over 20 specializing in consulting services, business processes, manufacturing, operations and R&D for the country’s top pharmaceutical, biotech and medical device companies.

Shelley has been a member of PDA for almost 20 years. She has served on many levels within PDA, including serving as the President of the Southeast Chapter, working with many national event planning committees, assisting with Task Force teams and co-leading technical writing projects. Shelley leads the PDA Facilities and Engineering IG, whose mission is advancing understanding of existing and cutting-edge facilities and engineering developments internationally by promoting scientifically sound, practical technical information and education for industry and regulatory agencies.

She has received PMP certification on top of her BS in Marine Biology, graduate studies in Physiology with a minor in Microbiology and a MBA in Global Management. She has served in both the United States Army and United States Marine Corps.

Morten Munk

Morten Munk

Fujifilm Diosunth

Morten Munk’s career is comprised of more than 30 years of experience within the global biopharmaceutical industry.

One common denominator for his approach is to have a holistic and a broad perspective on all aspects and steps in production of biopharmaceuticals. He believes; collaboration, knowledge sharing, and optimal use of all relevant technologies are the key factors in ensuring availability of the best product for the patient.

Morten joined Fujifilm as Director, Global Alliance Management in 2020. In 2001 he was one of the co-founders of CMC Biologics (now AGC Biologics), after working 14 years at Novo Nordisk.

Furthermore, Morten has authored or contributed to several technical articles and guidelines. He is frequently invited to give scientific and technical presentations at international conferences. Additionally, he is active in the biopharmaceutical community as member of scientific committees for various international conferences as well as volunteer in international industry organizations such as PDA, ISPE and BPOG.

Ed C. Tidswell, PhD, BSc

Ed C. Tidswell

Merck & Co., Inc.

Edward C. Tidswell, BSc, PhD - Dr. Tidswell is Executive Director within the Sterile and Microbiology QA organization of Merck. This role has ownership over microbiology issues across sterile and non-sterile sites within the Global Manufacturing Division. His prior appointments include global R&D, and quality leadership roles supporting and innovating across large volume parenteral, small volume parenteral (small molecules, biologics, vaccines), medical device and bulk API manufacturing and testing platforms for the likes of Baxter Healthcare, Eli Lilly and Evans Vaccines. Dr Tidswell continues to actively publish and is a leading authority on pharmaceutical microbiology, risk, aseptic and sterile manufacturing. From 2013-2019 he served on the PDA’s Science Advisory Board and is currently a member of the PDA Journal’s Editorial Board. In June 2010 Dr. Tidswell joined and continues to serve on the USP expert committee on Microbiology & Sterility Assurance, and Co-chairs USP's Modern Microbiological Methods program.

Diane M. Paskiet, MS

Diane M. Paskiet

West Pharmaceutical Services, Inc.

Diane Paskiet has over twenty years of experience with qualifying packaging and delivery systems for use with pharmaceutical products. She is Currently Director of Scientific Affairs at West Pharmaceutical Services where she is involved in science and regulatory programs associated with safety and compatibility of packaging systems. Previous to this role she was in charge of site operations for West-Monarch Analytical Laboratories. She is a co-recipient of the United States Pharmacopeia (USP) award for Innovative Response to a Public Health Challenge and Expert Committee member. She serves as Vice Chair of Product Quality Research Institute (PQRI) Development Technical Committee (DTC) and Chair of Parenteral and Ophthalmic Drug Product Leachables and Extractables Working Group.

Ms. Paskiet is also on the faculty of the Parenteral Drug Association Training Institute and author/co-author of papers related to pharmaceutical packaging.

Ghada N. Haddad, PhD

Ghada N. Haddad

Merck & Co., Inc.

Ghada Haddad is currently an Executive Director, leading the Global cGMP and Compliance Auditing Organization at Merck & Company. Prior to that she was the Head of the Global Quality Risk Management Center of Excellence, building a team of experts to develop and implement a robust and sustainable QRM program. She holds a chemistry degree and a PhD and an MBA with over 22 years of experience, working in the Biotech and Pharmaceutical industries in the areas of Quality Risk Management (QRM), Validation, Quality Systems and Regulatory, including research, management (people and projects), process development, auditing, regulatory agency inspection, change control and validation. Haddad was the chair of the Paradigm Change in Manufacturing (PCMO) initiative: QRM in Packaging and Labeling, QRM for the Design, Qualification, and Operation of Manufacturing Systems task forces, co-chaired the Aging Facilities Points to Consider and co-chaired the 2018 and 2019 Annual PDA Conferences and the 2019 PDA Quality Week. She is also a faculty member for PDA’s Training and Research Institute and a Science Advisory Board member and a member of the PDA Board of Directors.

Edward S. Balkovic, PhD

Edward S. Balkovic

Independent Consultant

Edward S. Balkovic, Ph.D. is currently an Independent Consulting Microbiologist / Virologist. He also holds an academic appointment as an Adjunct Associate Professor in Department of Cell & Molecular Biology at University of Rhode Island. His experience includes 40+ years in fields of Microbiology & Virology; 30+ years in Biologics & Biopharmaceutical industries; and 20+ years at Sanofi Genzyme. Before retiring from Sanofi Genzyme, he served as a Subject Matter Expert (SME) Microbiologist, established microbial identification laboratory serving Genzyme's QC Microbiology testing labs and conducted investigations, assessments, special projects, training and developmental technical seminars throughout Sanofi. Dr. Balkovic received his doctorate degree in Microbiology and Immunology in the Influenza Research Center at Baylor College of Medicine, Houston, TX. He has held various positions in Contamination Control, Technical Support, Quality Control, Quality Assurance, Regulatory Affairs, Facilities Operations, and Research & Development at both emerging biotechnology and established biopharmaceutical companies. He is a member of Parenteral Drug Association’s (PDA) Science Advisory Board. He also served on the Program Planning Committee for the PDA Global Pharmaceutical Microbiology Conference (2007 – 2017) and as Conference Co-Chair in 2009 and 2010. Recipient of 2017 PDA Distinguished Service Award.

Hal Baseman, MBA

Hal Baseman

ValSource LLC

Hal Baseman is chief operating officer and a principal at ValSource Inc. and ConcordiaValsource LLC. He has over 40 years of experience in pharmaceutical operations, validation, and regulatory compliance. He has held positions as the Chair of the PDA (Parenteral Drug Association) Board of Directors, the Co-Chair of the PDA Science Advisory Board, the Co-Leader of the PDA Aseptic Processing Points to Consider Task Force and the Co-Leader of the PDA Process Validation Interest Group, as well as a long-time member of the PDA Training Research Institute faculty. Hal holds an MBA in Management from LaSalle University and a B.S. in Biology from Ursinus College.

Chris J. Smalley, PhD

Chris J. Smalley

ValSource LLC

Chris Smalley has recently retired from Merck, where he had responsibility for innovative implementation and validation, including Single Use Systems globally. He now is a consultant for Valsource, focused primarily on Compounding Pharmacies. Previously, he had been Director of Quality Operations for Wyeth Pharmaceuticals for 12 years with responsibility for setting validation standards and validation activities globally. His research experience includes responsibility for Quality in the U.S. operations of the Sanofi Research Division, and earlier he had worked for the Johnson & Johnson family of companies, where he was a Plant Manager.

Chris retired after 21 years of service as a LtCol in the U.S. Air Force. Chris practiced as a compounding pharmacist across the military hospital system, compounding intravenous solutions and total parenteral nutrition products to meet physicians' orders. Chris is a graduate of the Philadelphia College of Pharmacy. His graduate education includes a MBA from Temple University Fox School of Business, a Masters of Science in Pharmaceutical Chemistry from Temple University School of Pharmacy, and a PhD in Healthcare Administration from LaSalle University.

Chris has been a member of the PDA Board of Directors, as well as a member of the PDA Science Advisory Board.

Maik W. Jornitz, MSEng

Maik W. Jornitz

G-CON Manufacturing

Maik W. Jornitz, CEO of G-CON Manufacturing Inc., is a technical expert with over 30 years of experience in bioprocesses, especially sterilizing grade filtration and single-use technologies, including regulatory requirements, integrity testing, systems design, and optimization. Jornitz has published 10 books, 15 book chapters and over 100 scientific papers. He is former chair of the PDA Science Advisory Board, task force member of Aging Facility and Post Approval Change Task Forces, as well as an advisory board member of the Biotechnology Industry Council, ICAV and multiple science journals. He recently has been recognized as one of the top ten global industry influencers. As a faculty member of multiple training activities, including PDA TRI, he trains members of the industry and regulatory authorities on a frequent basis. He received his M.Eng. in Bioengineering at the University of Applied Sciences in Hamburg, Germany and accomplished the PED program at IMD Business School in Lausanne, Switzerland.

Steven R. Mendivil, BS

Steven R. Mendivil

Amgen Inc.

Steven Mendivil is currently a part time contractor and Senior Advisor for Amgen in International Quality. He had been with Amgen for 19 years and was Executive Director of International Quality, External Affairs. He was previously head of Corporate Quality GMP & EHS and was on the ICH Q11 Expert Working Group and on the ICH Q7 Implementation Working Group. Prior to Amgen, Steve worked for 5 years at Genentech in Quality and 10 years at Syntex in Regulatory Affairs, Quality and Manufacturing. Steve also consults for a number of companies.

He was on the PDA Board of Directors as an Executive Officer and has led various external committees on GMP related topics. Steve is currently PDA’s Quality Metric /Culture Task Force leader.

He has also taught at UC Berkley extension course on Biotechnology and at USC graduate school for Regulatory Affairs.

Steve holds a BS from University of California at Davis and is Regulatory Affairs Certified (RAC) by the Regulatory Affairs Professional Society.

Related Events

2020 PDA Pharmaceutical Manufacturing Data Science Webinar Series

July 13-16, 2020 | Virtual

This multi-day webinar series will provide an interactive, virtual experience for managers in the pharmaceutical manufacturing field. Explore data science, analytics, artificial intelligence, and machine learning using standard IT tools and example data sets. Work closely with peers to solve data science challenges that you face every day.

Reasons to Attend

40+ Expert Speakers

Hear from experts with a variety of backgrounds, from pharmaceutical manufacturing, cloud technology, data science, and product quality, to the patient and healthcare perspectives. Each brings in-depth knowledge and insight providing you with a well-rounded, engaging meeting!

Keep Up with the Latest Innovations and Regulatory Updates

This is a time of unprecedented innovation and development. What does this change mean for the industry and regulatory authorities, and ultimately, how can we better serve patients? We’re going to be looking at breakthrough designations, modernization of facilities, leveraging data solutions, and ATMPs.

Invest in Your Future

This is your chance to build interdisciplinary professional connections while staying up to date on trends and research in the industry. Engage in live chat and set appointments with some of the industry’s leading suppliers in the Virtual Exhibit Hall. You can check out exhibitor videos, white papers, new product demos, win a prize, and more. Virtual exhibit hall booths will be open and representatives available during dedicated break times. In addition, the booths will be open 24/7 after the end of the sessions so you can still gather valuable technical information or send an email directly to exhibitors.

Connect with People Across the Bio/Pharmaceutical Industry

With a history of excellence connecting people, science, and regulation, PDA events are the place to expand your network. Get in-depth insight during poster presentations and mingle with thought leaders in virtual chat lounges during breaks.